BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1905704 · Received November 12, 2010

    Report

    Report Number
    2210968-2010-01502
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. IT SHOWS A FRACTURE AT THE NEEDLE POINT. A MICROSCOPIC INSPECTION REVEALED SEVERAL MARKS OF INSTRUMENT WERE FOUND IN THIS AREA, DIRECT AT THE BREAK POINT (AND ALSO AT THE ATTACHMENT AREA), WHICH INDICATES THAT THE NEEDLE WAS HANDLED THERE. THE BREAKPOINT SHOWS NO MATERIAL OR MANUFACTURING DEFECTS. CONCLUSION : THE DEVICE INFO FOR USE CAUTIONS THE USER THAT "TO AVOID DAMAGING THE NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE THIRD TO ONE-HALF THE DISTANCE FROM THE SWAGED END TO THE POINT. CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM HANDLING. AVOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS". IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01503. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC PROCEDURE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE NEEDLE TIP WAS FOUND AND TAKEN OUT OF THE PT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA CDE991

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK